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Stellenbeschreibung

Randstad Professionals is currently looking for a Regulatory Affairs specialist (German speaker) who will be assigned an interesting challenge for a major client based in the region of Solothurn. This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will in July 2018 and will last until December 2018.

Job description:

The focus of this position is to conduct a GAP analysis on the regulatory related technical documentation existing for China registrations through comparison with regulatory related technical documentation generated for CE marking.
In addition, the responsibilities of this position will also include:
• Assisting with reviewing of product and process documentation to ensure
compliance with change control requirements to aid determining if regulatory submissions are required
• Creation, review and maintenance of regulatory related technical documentation
• Supporting team's daily operations of regulatory processes
• Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals
• Providing progress of work-plans and the status of key project deliverables
What we require from the candidate:
• Previous experience with regulatory registrations in China would be an asset
• Knowledge of EU MDR, especially Council Directive 93/42/EEC
• Around 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
• Familiarity with Technical Documentation structure according to STED required
• Excellent skills in computer software such as MS Word, Excel, Powerpoint
• Strong Database skills
• Strong analytical skills and network thinking
• Excellent English spoken and written, German is an asset

If you are interested to learn more about this role, feel free to call me 0041 58 201 55 55 or send me an email to olivier.worch@randstad.ch